Kornimate/medical-research-clean huggingface dataset:
stanford kids camp study

Conditions: Pre-diabetes; Obesity; Type-2 Diabetes Mellitus

Summary: the stanford kids camp study aims to evaluate the feasibility of enrolling minority participants in school age children (5-13 years old) in a community summer camp setting along with the efficiency by which each participant's biologic specimens are collected. using remote monitoring technologies and through partnering with community-based organizations, the investigators hypothesize that an increase in underrepresented minority participation in a clinical trial that is greater than the national average is possible.

the proposed study is an outpatient prospective, open-label clinical trial comparing 2 groups: group 1 (aka bawsi camp): the dexcom g6 pro continuous glucose monitor and the accelerometer and mobile connected device, group 2 (aka ymca of silicon valley camp): the abbott freestyle libre 2 continuous glucose monitor and the accelerometer and mobile connected device. eligible subjects will be enrolled to each cohort based on their participation in the specific ymca camp site. the investigators will study up to 100 minority school-age children (5 - 13 years old) in the san francisco bay area a 5-day summer camp. the study will be split in 2 sequential phases: (a) the bawsi camp, (b) the ymca of silicon valley camp, following a repeated measures design with the 5-day camp being followed by 5 - 9 days at home, under parental supervision. study participants will be divided in two equal groups at each site with each wearing the specific manufacturers continuous glucose monitoring device.

Eligibility criteria:
inclusion criteria: * 5-13 years of age. * avoidance of acetaminophen-containing medications (i.e. tylenol) while wearing the continuous glucose monitor. * willingness to wear a continuous glucose sensor and physiological monitor for the duration of the study. * a parent/caregiver is available for system training and will commit to be the main responsible person for the use of the monitoring system at home. exclusion criteria: * have a condition limiting their participation in the interventions (e.g., unable to participate in routine physical education classes at school, requiring oxygen supplementation for exertion, developmental or physical disability preventing participation in interventions, children or parents/guardians who cannot medically participate in mild dietary restrictions and/or increased physical activity for any reason). * have a condition limiting participation in the assessments (child or primary caregiver not able to read surveys in english or spanish, child two or more grade levels delayed in school for reading and writing in her native language). * are unable to read, understand or complete informed consent in english or spanish. * are deemed to have another characteristic that makes them unsuitable for participation in the study in the judgment of the principal investigators.
fetal evaluation at term using statistical ecg signal processing (fetuses)

Conditions: Fetal Heart Rate Variability

Summary: background the fetal heart rate (fhr) is commonly monitored during labor to detect early fetal acidosis. fhr variability is traditionally investigated using fourier transform, however, fetal conditions differ from adults (higher frequency, widely instable signal) modifying spectrum repartition along frequencies, making this approach inappropriate. new mathematic approach, including multifractal analysis, adaptative multiscale complexity analysis, nearest-neighbor based wavelet entropy rate measures, scattering transform, may identify parameters associated with fetal acidosis. modern classification system, driven by the data, based on these relevant parameters should help to dsiccriminate the fetus at risk for acidosis and help the clinician in decision making for the management and termination of labor. analysing 20 to 30 minutes sliding windows with these different methods in a limited number of cases (foetus born with acidosis) and controls (foetus without acidosis) should lead to identify relevant parameters, which will be submitted to these classification tools. for external validation, a large database, including more than 4500 fhr recording documented with foetal outcomes, will be used to evaluate the performance of the combination of parameters identify and classification system used to discriminate foetuses at risk for short term acidosis or not, in order to give a relevant information to the clinician before acidosis occurs, to make the appropriate decision.


Eligibility criteria:
--- inclusion criteria: * women with singleton pregnancy and fetal ecg recording using a scalp electrode, with recording lasting more than 60 minutes, with less than 20 % of missing data and less than 20 minutes between the end of recording and birth. * exclusion criteria: * women with recirdin lasting less than 60 minutes, with more than 20 % of missing data, or more than 20 minutes between the end of recording and birth.

Keywords: fetal heart rate variability entropy multifractal analysis scattering transform sparse vector machine acidosis
a phase 3 study of solosec® for the treatment of trichomoniasis

Conditions: Trichomonas Infection

Summary: this is a phase 3, multi-center, prospective, randomized, placebo-controlled, delayed treatment, double-blind, study to evaluate the effectiveness, and safety of a single, oral dose of solosec® containing 2 grams of secnidazole in female patients with trichomoniasis.

the study will consist of a primary study phase (visit 1 (baseline) to visit 2 (day 6-12)) and a follow-up phase (visit 2 to visit 3 (7-12 days post visit 2)). during the primary phase patients will be randomly assigned in a 1:1 ratio to either solosec or placebo. patients will return to the clinic for the "test of cure" (toc) visit to be conducted on days 6-12 (visit 2). to ensure all patients receive treatment and to maintain the double-blind, after completion of the primary phase, patients will receive the opposite treatment , (placebo patients will receive solosec and vice versa). patients with v2 cultures that are subsequently positive for t. vaginalis will return to the clinic for visit 3 (v3) assessments and investigator assessment of need for additional therapy (an additional visit 4 may be scheduled at the investigator's discretion if culture at v3 is positive). summary of results includes data reported during the primary phase of the study \[visit 1 (baseline) to visit 2/toc (day 6-12)\]

Eligibility criteria:
inclusion criteria: * adult female or post-menarche adolescent girl ≥12 years of age in general good health * have a diagnosis of trichomoniasis at the screening visit as determined by one of the following: * positive t. vaginalis naat test within 30 days of screening for which treatment has not been initiated. * positive osom® rapid test. * positive wet mount assessment. * agree to abstain from vaginal intercourse until the final study visit * agree not to have any vaginal penetration or use of any vaginal products for the duration of the study exclusion criteria: * are pregnant, lactating, or planning to become pregnant during the study. * are suspected clinically (or confirmed diagnostically) of having alternative causes of vaginal symptoms including symptomatic vulvovaginal candidiasis, chlamydia, gonorrhea, or an active genital herpes outbreak * are suspected clinically of having an acute urinary tract infection. * have active genital lesions, including primary syphilitic chancres and herpes simplex virus lesions, or other vaginal or vulvar conditions which could confound the interpretation of the clinical response, as determined by the investigator (patients with genital warts may be enrolled). * have received systemic antibacterial therapy or topical antimicrobial/antifungal/ immunomodulatory therapies in the genital area (vagina, vulva and surrounding soft tissue), within 14 days prior to the baseline visit (day 1).

Keywords: vaginal itching vaginal discharge
comparison of kinesio taping and dry needling in grade 1, 2 knee osteoarthritis

Conditions: Osteoarthritis, Knee

Summary: this study's aim was: - to determine the effects of kinesio taping and dry needling on pain, roms, functional mobility, and quality of life in knee oa patients.

this was a randomized clinical trial in which grade 1, 2 knee osteoarthritis patients were randomized into two groups: group-a and group-b. group-a participants received kinesio taping while group-b participants received dry needling as an adjunct to the conventional physical therapy treatment. the intervention was carried out for four weeks with frequency of two sessions per week. outcome measures were assessed at baseline, after two weeks, and after 4 weeks, using visual analog scale (vas), western ontario and mcmaster universities osteoarthritis index (womac), knee range of motion (rom), and sf-12 quality of life questionnaire.

Eligibility criteria:
inclusion criteria: * clinically diagnosed patients of grade 1, 2 knee oa (kallgren and lawrence). * pain and/or tenderness around knee joint * knee oa patients with tightness in quadriceps, hamstrings, and iliotibial band. * patients with pain of \>4 on vas. exclusion criteria: * patients who had received intra-articular steroid injections in knee joints. * patients who had suffered a traumatic injury to knee joint within past 6 months prior to this study. * patients with any surgical intervention to the knee joints. * patients with peripheral vascular disease. * patients with diagnosed tumors, malignancies, infection associated with knee joint. * patients with lower limb metallic implants.

Keywords: dry needling joint flexibility kinesio tape knee osteoarthritis pain quality of life
effect of the automatic surveillance system on surveillance rate of patients with gastric premalignant lesions

Conditions: Artificial Intelligence; Surveillance

Summary: in this study, we proposed a prospective study about the effect of the automatic surveillance system on surveillance rate of patients with gastric premalignant lesions. the enrolled patients were divided into group a with intelligent surveillance system, group b with manual reminder, and group c with natural state. the surveillance among the three groups will be compared.

the adherence of doctors to published surveillance guidelines for patients with gastric premalignant lesions varies greatly, and surveillance of patients is critical but time-consuming. in previous studies we developed an automatic surveillance (as) system to accurately identify patients with gastric premalignant lesions, assign surveillance intervals for different risks of patients and proactively follow up with patients in time. in this study, we proposed a prospective study about the effect of the automatic surveillance system on surveillance rate of patients with gastric premalignant lesions. the enrolled patients were divided into group a with intelligent surveillance system, group b with manual reminder, and group c with natural state. the surveillance among the three groups will be compared.

Eligibility criteria:
inclusion criteria: * male or female aged 18 years or older who undergo upper endoscopy. exclusion criteria: * 1)no contact information or invalid contact information. * 2) the surveillance interval cannot be determined according to the surveillance guidelines, including no upper gastrointestinal pathology, therapeutic endoscopy or with history of previous gastrectomy, esophagectomy, or esd, no dysplasia degrees, no biopsy sites, non-epithelial lesions, duodenal lesions, ulcer and so on. * 3) needless for surveillance or others. * 4) high-grade intraepithelial neoplasia or cancer of the esophagus or stomach. * 5) low-grade intraepithelial neoplasia of the esophagus and barrett's esophagus. * 6) high-risk diseases or other special conditions for which the patient is deemed unsuitable for clinical trials by the investigator.

Keywords: surveillance rate automatic surveillance
early response assessment in diffuse large b-cell lymphoma (dlcl) patients by 18-fluoro-2-deoxyglycose positron emission tomography (fdg-pet)

Conditions: Diffuse Large B-cell Lymphoma

Summary: newly diagnosed dlcl patients will have baselne fdg-pet as part of initial staging (pet-1). patients will then undergo 2 cycles of chemotherapy with r/chop. 14 to 21 days following cycle 2 of r/chop, patients will undergo repeat fdg-pet scan (pet-2). they will then complete therapy as planned. following completion of therapy, standard response assessment will be performed, including ct scans of the chest, abdomen and pelvis and fdg-pet scan (pet-3).


Eligibility criteria:
inclusion criteria: * patients must have histologically or cytologically confirmed diagnosis of cd20+ diffuse large b cell lymphoma (lbcl) of any stage, including subtypes mediastinal large b cell, centroblastic, immunoblastic, t cell rich b cell and anaplastic b cell lymphoma * patients must have received no prior anti-lymphoma therapy. * age \>18 years. * patients must have a treatment plan to include r/chop or r/chop followed by radiotherapy. * ability to understand and the willingness to sign a written informed consent document. exclusion criteria: * patients who have known hiv infection. * patients who are, in the opinion of their treating oncologist, unable to undergo r/chop chemotherapy.

Keywords: diffuse large b cell lymphoma newly diagnosed
insightrp2 registry

Conditions: RP2-associated Retinitis Pigmentosa; X-Linked Retinitis Pigmentosa (XLRP); Retinitis Pigmentosa 2

Summary: insightrp2 is a secure online patient registry specific to rp2-associated retinitis pigmentosa (rp). it is our goal to further the scientific understanding of this rare disease and to support research in to a gene therapy for rp2-associated rp. we collect medical, genetic and imaging data from people affected by rp2-associated rp and will coduct a natural history study as well as image analysis studies.

there is currently no specific patient registry for rp2-associated retinitis pigmentosa. due to the rarity of the disease, only a few patients with this disease are seen at various care sites, making clinical care and diagnosis very challenging. in addition, there are numerous knowledge gaps regarding the course of the disease, the disease mechanisms and therapeutic approaches, which poses additional challenges for patient care. understanding and future treatment of rp2-associated rp is crucial due to its early onset and rapid progression. there is an urgent need for targeted research to develop effective therapies. at the institute of human genetics göttingen, we have set ourselves the goal of investigating the disease mechanisms of rp2-associated rp and contributing to the long-term development of a therapy for this rare disease. for this purpose, we have set up a patient registry specifically for rp2-associated rp. the registry is fully online, using a secure redcap-based database hosted at the university medical center göttingen. the medical data collected will enable us to conduct studies on the natural history, mutation distribution and possible genotype-phenotype correlations of this disease. in addition, the collection of medical image data will enable evaluation for the purpose of improving diagnostic processes and supporting therapeutic studies. last but not least, we aim to form a patient collective who can be offered participation in possible therapy studies at a later date. we will collect retrospective data, however patient's might be recontacted at a later timepoint, which is why we have designated the time perspective as "other" in the description of the study design.

Eligibility criteria:
inclusion criteria: * a molecular genetic diagnosis involving a heterozygous or hemizygous variant in rp2 and a written informed consent to participate are required for access to the registry questionnaire. patients of all ages meeting the above criteria will be allowed to participate. as documentation will be in english and german, those who can navigate these pages will be included. exclusion criteria: * patients with evidence of non-rp2 molecular genetic diagnoses will be excluded. collection of data and further analysis will not be possible without the consent of the patient or legal guardian. patients who cannot navigate registry documentation in english or german will be excluded.

Keywords: rp2, retinitis pigmentosa, rp2-associated retinitis pigmentosa
respiratory disease management

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the aim of this study is to reduce the number of subsequent hospital admissions and/or emergency department (ed) visits for hospitalized patients with chronic obstructive pulmonary disease (copd) by utilizing a respiratory care practitioner-led disease management (rcp-dm) program compared to standard discharge instructions and planning.

the investigators propose to carry out a prospective, randomized, trial at barnes-jewish hospital (1250-bed urban academic hospital). eligible patients will be identified by a senior study coordinator who will also obtain informed consent for study participation. adults greater than 18 years of age and less than 65 years of age will be eligible for enrollment if the lead investigator and the treating physician agree that the patient meets the enrollment criteria which include the following: patients with spirometrically confirmed copd at high risk for repeat hospitalization or ed visits as predicted by hospital admission or ed visit in the previous 12 months for a copd exacerbation, chronic home use of oxygen, or a course of systemic corticosteroid therapy in the preceding 12 months. exclusion criteria include patients not expected to survive their hospitalization, presence of metastatic cancer, bed-bound individuals, non-english speaking patients, and patients unable to provide informed consent.

Eligibility criteria:
inclusion criteria: * adults greater than 18 years of age and less than 64 years of age will be eligible for enrollment if the lead investigator and the treating physician agree that the patient meets the enrollment criteria which include the following: * patients with spirometrically confirmed copd at high risk for repeat hospitalization or emergency department (ed) visits as predicted by hospital admission or ed visit in the previous 12 months for a copd exacerbation, * chronic home use of oxygen, or * a course of systemic corticosteroid therapy in the preceding 12 months. exclusion criteria: * patients not expected to survive their hospitalization, * presence of metastatic cancer, * bed-bound individuals, * non-english speaking patients, and * patients unable to provide informed consent.

Keywords: copd
safety and efficacy trial of aav gene therapy in patients with cnga3 achromatopsia (a clarity clinical trial)

Conditions: Achromatopsia

Summary: this will be a non-randomized, open-label, phase 1/2 study of the safety and efficacy of agtc-402, administered to one eye by subretinal injection in individuals with achromatopsia caused by mutations in the cnga3 gene. the primary study endpoint will be safety and the secondary study endpoint will be efficacy.

this will be a non-randomized, open-label, phase 1/2 study of the safety and efficacy of agtc-402 administered to one eye by subretinal injection in individuals with achromatopsia caused by mutations in the cnga3 gene. the primary study endpoint will be safety and the secondary study endpoint will be efficacy. subjects will be enrolled sequentially in six groups. subjects in groups 1, 2, 3, 4, and 5 will be at least 18 years of age and will receive varying dose levels of study agent. subjects in group 3a will be 6 to 17 years of age and will receive the same dose as group 3. subjects in group 4a and 6 will be between 4 and 8 years of age. subjects in group 4a will receive the same dose as group 4, and subjects in group 6 will receive the maximum tolerated dose identified in groups 1, 2, 3, 3a, 4, 4a, and 5. safety will be monitored by evaluation of ocular and non-ocular adverse events and hematology and clinical chemistry parameters. efficacy parameters will include visual acuity, light discomfort testing, color vision, static visual field, erg, adaptive optics retinal imaging, functional mri (fmri), color brightness test and oct.

Eligibility criteria:
inclusion criteria: 1. male or female subjects with documented mutations in both alleles of the cnga3 gene; 2. retinal disease consistent with a clinical diagnosis of achromatopsia; 3. at least 18 years of age for groups 1, 2, 3, 4, and 5. at least 6 years of age for group 3a, and and 4-8 years of age for groups 4a and 6; 4. able to perform tests of visual and retinal function; 5. visual acuity in the study eye not better than 55 etdrs letters (snellen equivalent 20/80) based on the average of two examinations at the baseline visit; 6. acceptable laboratory parameters; 7. for females of childbearing potential: a negative pregnancy test within 2 days before administration of study agent. exclusion criteria include: 1. best-corrected visual acuity difference between the two eyes of \> 15 etdrs letters (3 lines); 2. evidence of degenerative myopia in the study eye; 3. pre-existing eye conditions that would contribute to vision loss in either eye or increase the risk of subretinal injection in the study eye.

Keywords: color vision deficiency color vision defects vision disorders sensation disorders neurologic manifestations nervous system diseases eye diseases signs and symptoms
impact of fluoride vanish application in dental prevention for elderly

Conditions: Tooth Decay

Summary: this study questions the interest of fluoride varnish dental application in preventing tooth decay in a population of institutionalised elderly people.

application of fluoride varnish on one side of the mandibles (left or right, randomly selected) in a population of institutionalised elderly people.

Eligibility criteria:
inclusion criteria: * patient hospitalised in nursing home or long-stay hospital department * patient older than 18 years old * obtention of informed consent * 3 or more healthy or treated teeth on each side (left and right) of the mandibles exclusion criteria: * patient in palliative care or end-of-life care * patient without social security affiliation * patient participating in another research dealing with dental care * contra-indication to fluoride varnish

Keywords: tooth-decay prevention fluoride-varnish institutionalised elderly people
urinary neutrophil gelatinase-associated lipocalin (ungal) in invasive cardiology

Conditions: Renal Failure

Summary: diagnosis of acute kidney injury (aki) relies on a late marker, namely serum creatinine (scr). new biomarkers are considered for early and sensitive detection of cin. in particular, ungal has been used for early detection of aki in the emergency department, after cardiopulmonary bypass or following cm administration. this study will be conducted to assess the possible value of urinary neutrophil gelatinase-associated lipocalin (ungal) as an early detector of contrast-induced nephropathy (cin) in a large sized cohort of patients undergoing percutaneous coronary procedures (pcp) and whether or not ungal correlates with the volume of contrast medium (cm) used.

methods. we will enroll all consecutive patients undergoing pcp with iomeprolum during a 3-month period at our institution. cin will be defined as a ≥25% increase in scr from baseline when measured 2-4 days after pcp. ungal will be measured at its peak with the abbott architect assay.

Eligibility criteria:
inclusion criteria: * all except patients with exclusion criteria exclusion criteria: * dialysis-dependent chronic kidney disease * lack of written consent

Keywords: renal failure cardiology contrast-induced nephropathy